En­docrine ex­perts at Cri­net­ics bag $63.5M to push R&D on an ex­per­i­men­tal pill for acromegaly

R. Scott Struthers

It’s been more than two years since Cri­net­ics bagged its $40 mil­lion launch round to get start­ed on pipeline build­ing. And now that they’re in­to the clin­ic with their first drug, they just scored an ex­tra $63.5 mil­lion to pur­sue some clin­i­cal proof-of-con­cept da­ta to show the world if they’re on the right track.

San Diego-based Cri­net­ics was found­ed by three key play­ers out of Neu­ro­crine Bio­sciences: CEO R. Scott Struthers, VP of chem­istry Frank Zhu and Stephen Betz, the VP of bi­ol­o­gy.

They had all worked on non­pep­tide GnRH an­tag­o­nists, and Struthers was in charge of the orig­i­nal team de­vel­op­ing elagolix, lat­er out­li­censed to Ab­b­Vie (and just to­day suc­cess­ful­ly through its sec­ond Phase III for uter­ine fi­broids). It’s wide­ly ex­pect­ed to be ap­proved soon for en­dometrio­sis.

Frank Zhu

The team at Cri­net­ics have been work­ing on new drugs af­ter de­vel­op­ing some nov­el thoughts about the way GPCRs work. The lead pro­gram is fo­cused on acromegaly, a rare dis­ease trig­gered when the pi­tu­itary gland pro­duces ex­cess growth hor­mone, caus­ing en­larged bones that can lead to gi­gan­tism, which caused An­dre the Gi­ant to swell in size. It al­so ul­ti­mate­ly killed him.

So­mato­statin can rein that in, but syn­thet­ic so­mato­statin analogs don’t al­ways work. That leaves the biotech in the hunt for a small mol­e­cule that can. They al­so have a grow­ing pre­clin­i­cal pipeline be­hind that.

Stephen Betz

Per­cep­tive Ad­vi­sors led the round, with new in­vestors RA Cap­i­tal and Or­biMed jump­ing in. Ex­ist­ing in­vestors 5AM Ven­tures, Ver­sant Ven­tures and Vi­vo Cap­i­tal al­so took part.

The biotech is con­duct­ing a Phase I study for the non­pep­tide so­mato­statin ag­o­nist CRN00808. And they start­ed out work­ing with the be­lief that a small team could man­age this through Phase III.

“A small com­pa­ny,” Struthers told me back in 2015, “could take this all the way.”

They now have the mon­ey to see if they can take it much fur­ther in­to the clin­ic.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Jonathan Montagu, HotSpot Therapeutics CEO

Ab­b­Vie puts up $40M to li­cense a treat­ment from HotSpot Ther­a­peu­tics

HotSpot Therapeutics has managed to gain some steam financially in the past few years, as the company wrangled several multi-million dollar raises. But its latest deal not only puts more cash into its pockets, it also connects with a major name in pharma.

On Tuesday, AbbVie and HotSpot announced they have entered an “exclusive” global collaboration, with the option to license HotSpot’s IRF5 program, which is designed to treat autoimmune diseases. The deal will see AbbVie hand HotSpot $40 million upfront, with the biotech eligible to receive $295 million in “option fees” and R&D milestones.